State “Right-To-Try” Laws Gain Momentum

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In an example of life imitating art, several states are considering “right-to-try” legislation to make experimental drugs—drugs that don’t have FDA approval—available to the terminally ill.  Colorado and Louisiana have already approved such laws.  Others, such as Minnesota, Missouri and Arizona, currently have bills pending or up for referendum vote.

Some observers believe that the movie Dallas Buyers Club provided momentum to the movement.  In that movie Matthew McConaughey won an Oscar for his characterization of an AIDS patient in the 1980s desperate for unapproved drugs for himself and others.

Since 2009 the FDA has maintained a “compassionate use” program allowing seriously ill and dying patients to use experimental drugs as a last resort, provided they have the permission of both a physician and the manufacturer.  According to today’s issue of Governing, the FDA  receives 1,037 requests annually and approves 1,031.  But right-to-try advocates claim that the difficulty of navigating the FDA program explains the low number of applicants.

The Pharmaceutical Research & Manufacturers of America (PhRMA) objects to approaching the issue on a state-by-state basis.  Others object to the movement on the theory that it will lead to a decline in people willing to undergo clinical trials.  The FDA itself has taken no position on the issue.

 


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Faegre Baker Daniels | Attorney Advertising

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